Comparison of Intravitreal Dexamethasone Implant and Ranibizumab in Vitrectomized Eyes with Diabetic Macular Edema

Abstract

Purpose. This retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution. Methods. Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6. Results. Twenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ ( p > 0.05 ). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 ( p < 0.05 ). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p = 0.04 ), more mean visual gain (−0.30 logMAR vs. −0.15 logMAR, p = 0.02 ), lower mean final CFT (310.9 μm vs. 384.2 μm, p = 0.04 ), and larger mean CFT decrease (−150.0 μm vs. −60.1 μm, p = 0.03 ) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001 ) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p = 0.0002 ) were demonstrated in the IDI group than those in the IVR group. Conclusion. We concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.

Dexamethasone Intravitreal Implant (Ozurdex)

“…This approach is not recommended because P values comparing the baseline factors between treatment groups are influenced by sample size. 52 There appeared to be differences between the matched groups based on the percentages -for example, 39.5% versus 47.7% of patient eyes were pseudophakic at baseline in the anti-VEGF and dexamethasone groups, respectively -yet the P value for the difference between these was 0.49. Therefore, it is not clear whether the groups were adequately matched, and this may reflect the small sample sizes per group.…”

“…Wang et al (2021) 53 was a single-centre, retrospective observational study that investigated the effectiveness and safety of dexamethasone implants in eyes that were inadequately responding to anti-VEGF therapy (group 1) and treatment-naive eyes (no treatment within the 3 months before the study) (group 2) over a 6-month follow-up time point.53 At baseline, 34 eyes (in 31 patients) were included in group 1 and 41 eyes (from 38 patients) were included in group 2. The mean change in BCVA from baseline to month 6 in ETDRS was 7.29 (SD = 16.22) letters in group 1 versus 16.42 (SD = 14.38) letters (P value for ETDRS letters = 0.0008) in group 2.…”

Anatomical and visual outcomes of Retreatment with Intravitreal Dexamethasone Implant versus shifting to intravitreal Aflibercept for refractory Diabetic macular edema after an initial Intravitreal Dexamethasone Implant.

“…been commonly encountered by retina specialists, due to the chronicity of the underlying pathology and the frequency of anti-VEGF treatments. It has been managed by one or more of the following options: Ranibizumab 6,11 , Aflibercept [19][20][21][22] , IVTA 12,13 , DEX [14][15][16][17][18] , and pars plana vitrectomy [7][8][9] .…”

“…It is a micronized dexamethasone, that is placed in a biodegradable copolymer of polylactic-co-glycolic acid, which slowly releases dexamethasone into the vitreous over a period of up to six months. Intravitreal DEX implants received FDA approval following the results of the MEAD study [14][15][16][17][18] . fused with VEGF receptors 1 and 2 [19][20][21][22] .…”

Efficacy and safety of the dexamethasone implant in vitrectomized and nonvitrectomized eyes with diabetic macular edema: A systematic review and meta-analysis

“…They reported significant BCVA and CMT improvement at 8 and 26 weeks after receiving a single intravitreal injection. Additionally, a retrospective study demonstrated that the DEX implant achieved significantly better anatomical/visual improvement and fewer injections than intravitreal ranibizumab in the treatment of vitrectomized eyes with DME ( Wang et al, 2021 ).…”